Bowel management system

ABSTRACT

A bowel management system includes a waste collection catheter having at least two distinct sections. The first section is patient proximal when disposed in the patient&#39;s rectum and has durometer hardness in the range of about 50A to about 90A. The second catheter section is connected to the first section and has durometer hardness in the range of about 5A to about 49A. A selectively collapsible, substantially spherical retention balloon is attached coaxially and exterior of the first catheter section such that the proximal-most end of the retention balloon is coincident to the proximal-most end of the first section of the waste collection catheter, the substantially spherical retention balloon having an inflated size so as to be sufficiently large enough to retain the patient proximal end of the catheter in the patient&#39;s rectum without being so large as to trigger a defecatory response in the patient.

FIELD OF THE INVENTION

[0001] The present invention relates generally to the field of devicesfor bowel maintenance, and, more particular, to a rectal catheter havingmultiple sections of varying durometer hardness and a retention balloonto retain the catheter within the rectum of incontinent patients.

BACKGROUND OF INVENTION

[0002] Many circumstances can result in an individual becomingincontinent for an extended period of time. Examples of suchcircumstances include head or spinal cord trauma, disabling strokes,microbial caused illness, broken lower limbs or pelvic bones, digestivedisorders, intensive care stays, and as side effects of administrationof various pharmaceuticals. Incontinent patients and their caretakersface a great burden in the maintenance of the bowel and its functions.Such patients often suffer from constipation, but can also experienceboughts of diarrhea, which impose even greater nursing problems.Constipation or stool impaction can be painful and require messy bowelirrigations and/or manual disimpaction to break up the impacted stool.Diarrhea, on the other hand, can result in perianal skin breakdown,which in turn can lead to open wounds and infections. The propertreatment of perianal wounds, whether caused by exposure to feces (i.e.diarrhea) or other etiology, can be especially difficult if the wound iscontinually being contaminated by feces. A great deal of time isnecessary to cleanse contaminated wounds, change bedding and treatinfections. Thus, there is a great need for devices and methods toimprove the function of the bowel in incontinent patients. This need isparticularly great in patients who are incontinent as well as beingnonambulatory.

[0003] Previously, efforts to address these problems included a varietyof devices, such as bags or plugs adhered to or inserted into the anusof non-ambulatory patients. These methods are limited in theireffectiveness, in part due to leakage around the devices and theresultant effluent that remains in contact with the perianal skin and,in part, due to the complexities of the anal canal anatomy that caninterfere with the use of such devices. Because of the ineffectivenessof the available methods for managing fecal evacuation in bed-riddenpatients, physicians are frequently forced to construct a stoma in thoseindividuals where enough intact perianal skin does not remain or wherethe occurrence of an infection would be life threatening.

[0004] Thus, it is among the advantages and features of the presentinvention that it can be used as a bowel maintenance system in a widevariety of incontinent patients for diversion of fecal matter to areceptacle to minimize contact of such fecal matter with patient skin.The new system (1) facilitates the collection of fecal matter forpatients requiring stool management (2) provides access for colonicirrigation and (3) provides a conduit through which medications may beadministered.

SUMMARY OF INVENTION

[0005] Thus, it was with the above disadvantages and limitations in mindthat the new bowel management system was developed. The new system iscomposed generally of a rectal catheter having three distinct portions,each with different elasticity and durometer hardness. A retentionballoon mounted on the outer diameter of the patient proximal cathetermaintains the catheter in a position within the rectum that provides foratraumatic sealing and anchoring. An optional intralumenal balloonmounted on the inner diameter of the catheter assists in insertion ofthe device into a patient's rectum and also acts as an anti-reflux valveto obstruct the catheter's evacuation lumen during periods of bowelirrigation or following medication administration for the purpose ofretaining the medications in the patient's rectum. An optional faceplatethat can be anchored to the patient with tape prevents migration of theretention balloon too far into the rectum. A drainage tube extendsoutwardly from the external retention faceplate and functions as aconduit to transport waste and irrigation fluids away from the patientto a waste collection bag. A flush/sampling port is located on thedrainage tube and provides access for catheter flushing (rinsing) andstool sampling.

[0006] The catheter of the new system preferably includes three syringeconnectors. One of the connectors is in fluid communication with theretention balloon and one of the connectors is in fluid communicationwith the intralumenal balloon. These connectors facilitate theinflation/deflation of the respective balloons. The third connector isin fluid communication with an optional irrigation lumen that exits thecatheter at the patient proximal tip and is used for bowel irrigationand administration of medication solutions.

[0007] Accordingly, in furtherance of the above goals, the presentinvention is, briefly, a bowel management system for use in a patient.The new system includes a waste collection catheter having at least twodistinct sections of varying durometer hardness. A first section, whichis patient proximal and which is disposed in the patient's rectum innormal use position, has a first end and a second end, and a durometerhardness in the range of about 50A to about 90A, so that the catheterpatient proximal section is stiff enough to automatically maintain anopen position for free flow of bowel waste when in normal use positionwith a retention balloon inflated. However, the first section is softand pliable enough to permit folding longitudinally for ease ofinsertion into the rectum of the patient. A second section has a firstend connected to the second end of the patient proximal section, and asecond end, and a durometer hardness in the range of about 5A to about49A. The second section can be positioned and retained in the anal canalof the patient for extended periods without distending the sphincters orcausing discomfort. The system also includes a selectively collapsible,substantially spherical retention balloon attached coaxially andexterior of the patient proximal first catheter section such that theproximal-most end of the retention balloon is coincident to theproximal-most first end of the patient proximal first section of thewaste collection catheter. The substantially spherical retention balloonhas an inflated size so as to be sufficiently large enough to retain thepatient proximal end of the catheter in the patient's rectum withoutbeing so large as to trigger a defecatory response in the patient.

[0008] The present invention is also, briefly, the combination of abowel management system for use in a non-ambulatory patient and a wastecollection bag. The bowel management system includes a waste collectioncatheter having at least two distinct sections of varying durometerhardness including a patient proximal first section, which is disposedin the patient's rectum in normal use position, having a first end and asecond end. The durometer hardness of the first section is such that thecatheter patient proximal section is stiff enough to automaticallymaintain an open position for free flow of bowel waste when in normaluse position, yet is soft and pliable enough to permit foldinglongitudinally for ease of insertion into the rectum of a patient. Asecond section has a first end connected to the second end of thepatient proximal first section, and a second end sufficiently spacedfrom the first end that the second section can be positioned andretained in the anal canal of the patient and has a durometer hardnessto permit the retention of the second section in the patient forextended periods without causing discomfort or lesions in the patient. Awaste collection bag is adapted for secure, leak-proof connection to thewaste collection catheter and is sized sufficiently large enough toreceive fecal waste from the patient for extended periods, in the rangeof at least four hours.

[0009] The invention is further, briefly, a method for inserting a bowelmanagement system into a patient, the method including:

[0010] (a) providing a bowel management system, the system having:

[0011] a waste collection catheter having at least two distinct sectionsof varying durometer hardness including:

[0012] a first section which is patient proximal and which is disposedin the patient's rectum in normal use position, having a first end and asecond end, and a durometer hardness in the range of about 50A to about90A, so that the catheter patient proximal section is stiff enough toautomatically maintain an open position for free flow of bowel wastewhen in normal use position with retention balloon inflated, yet is softand pliable enough to permit folding longitudinally for ease ofinsertion into the rectum of a patient;

[0013] a second section having a first end connected to the second endof the patient proximal section, and a second end, and a durometerhardness in the range of about 5A to about 49A, so that the secondsection can be positioned and retained in the anal canal of the patientfor extended periods without distending the sphincters or causingdiscomfort; and

[0014] a selectively collapsible, substantially spherical retentionballoon attached coaxially and exterior of the patient proximal firstcatheter section such that the proximal-most end of the retentionballoon is coincident to the proximal-most first end of the patientproximal first section of the waste collection catheter, thesubstantially spherical retention balloon having an inflated size so asto be sufficiently large enough to retain the patient proximal end ofthe catheter in the patient's rectum without being so large as totrigger a defecatory response in the patient;

[0015] (b) folding the patient proximal first end of the wastecollection catheter longitudinally;

[0016] (c) inserting the folded patient proximal first end of the wastecollection catheter into the patient's rectum sufficiently far that theselectively collapsible, substantially spherical retention balloon isentirely within the patient's rectum; and

[0017] d) securing the waste collection catheter in the position towhich it has been inserted so that the catheter does not becomeseparated from the patient during an extended period of time, in therange of hours, while the patient's body waste is permitted to drain outof the patient's body through the waste collection catheter.

[0018] The invention is further, briefly, a method for inserting a bowelmanagement system into a patient, the method including:

[0019] (a) providing a bowel management system, the system having:

[0020] a waste collection catheter having at least two distinct sectionsof varying durometer hardness including:

[0021] a first section which is patient proximal and which is disposedin the patient's rectum in normal use position, having a first end and asecond end, and a durometer hardness in the range of about 50A to about90A, so that the catheter patient proximal section is stiff enough toautomatically maintain an open position for free flow of bowel wastewhen in normal use position with retention balloon inflated, yet is softand pliable enough to permit folding longitudinally for ease ofinsertion into the rectum of a patient;

[0022] a second section having a first end connected to the second endof the patient proximal section, and a second end, and a durometerhardness in the range of about 5A to about 49A, so that the secondsection can be positioned and retained in the anal canal of the patientfor extended periods without distending the sphincters or causingdiscomfort; and

[0023] a selectively collapsible, substantially spherical retentionballoon attached coaxially and exterior of the patient proximal firstcatheter section such that the proximal-most end of the retentionballoon is coincident to the proximal-most first end of the patientproximal first section of the waste collection catheter, thesubstantially spherical retention balloon having an inflated size so asto be sufficiently large enough to retain the patient proximal end ofthe catheter in the patient's rectum without being so large as totrigger a defecatory response in the patient;

[0024] b) inflating an intralumenal balloon in the patient proximal endof the waste collection catheter to the extent that the intralumenalballoon extends slightly beyond the proximal-most end of the catheter,to thereby provide a curved tip for ease of introduction of the catheterinto the patient's rectum

[0025] (c) inserting the patient proximal first end of the wastecollection catheter into the patient's rectum sufficiently far that theselectively collapsible, substantially spherical retention balloon isentirely within the patient's rectum; and

[0026] (d) securing the waste collection catheter in the position towhich it has been inserted so that the catheter does not becomeseparated from the patient during an extended period of time, in therange of hours, while the patient's body waste is permitted to drain outof the patient's body through the waste collection catheter; and

[0027] (e) deflating the intralumenal balloon in the patient proximalend of the waste collection catheter to permit free flow of body wastesfrom the patient.

[0028] These and other objects and advantages will be in part apparentand in part pointed out herein below.

BRIEF DESCRIPTION OF DRAWINGS

[0029]FIG. 1 is a schematic perspective view of a bowel managementsystem constructed in accordance with and embodying the presentinvention and shown inflated in the use position.

[0030]FIG. 2 is a schematic perspective view of the system of FIG. 1,shown partially exploded.

[0031]FIG. 3 is a schematic representation of the exterior of the rectaltube subassembly of the system of FIG. 1.

[0032]FIG. 3A is an exploded view of the subassembly of FIG. 3.

[0033]FIG. 4 is a side elevational view of the drainage tube assembly ofFIG. 1 with a bag connector attached thereto.

[0034]FIG. 5 is an exploded view of FIG. 4.

[0035]FIG. 6 is a schematic side view of the patient proximal end of theassembled bowel management system.

[0036]FIG. 7 is a longitudinal section, enlarged, through the patientproximal end of the system of FIG. 1 taken on line 7-7 of FIG. 6 andfurther enlarged for clarity of detail.

[0037]FIG. 8 is an enlarged schematic elevational view of the rectaltube of the assembly of FIG. 1.

[0038]FIG. 9 is a longitudinal sectional view taken on line 9-9 of FIG.8.

[0039]FIG. 10 is a transverse sectional view taken on line 10-10 of FIG.8.

[0040]FIG. 11 is an enlarged schematic sectional view of the tri-lumentube of the assembly of FIG. 1.

[0041]FIG. 12 is an enlarged partial sectional view showing the lumens,taken from FIG. 9.

[0042]FIG. 13 is a left end elevational view of FIG. 3, rotated.

[0043]FIG. 14 is an enlarged sectional view taken from FIG. 13 showingthe connection of the tri-lumen tube to the rectal tube.

[0044]FIG. 15 is a schematic elevational view of a waste collection bagused with the system with its various tubes and connectors.

[0045] Throughout the drawings like elements are indicated by likeelement numbers.

DETAILED DESCRIPTION

[0046] With reference to the figures, and particularly FIGS. 1 and 2, abowel management system, generally designated 10, includes a catheter 12having a patient proximal end 14 and a patient distal end 16 and threedistinct sections 18, 20, 22 therebetween. Rectal catheter section 18 islocated at the proximal end 14 of the catheter, section 20 is amidsection and section 22 is toward the patient distal end 16. A firstballoon 24, which is inflatable, is mounted at the patient proximal end14 of catheter 12 and a bag connector assembly 26 is mounted at thepatient distal end 16. These elements will be described in furtherdetail hereafter.

[0047] Rectal catheter section 18 has a patient proximal opening that,when positioned for normal use, opens into the rectum of a patient and asecond end or distal opening which connects to the second cathetersection 20. First catheter section 18 (shown enlarged in FIGS. 8, 9, 10and 12) is formed of a material having a durometer hard enough tomaintain a sufficient opening at the first end of the tube, in order toavoid collapse and subsequent blocking of fecal outflow from thepatient. An example of a suitable material is silicone rubber, 80 SHpolydimethylsiloxane and fumed silica. The optimal durometer range isbetween 50A and 90A shore hardness. The proximal opening must be keptopen, in order to effectively receive stool entering the first cathetersection 18. A relatively large lumen which runs longitudinally withinthe cylindrical wall of tube section 18 is indicated at number 30 inFIGS. 8, 9, 10 and 12. Smaller lumens 32, 34 are located adjacent andparallel to lumen 30 on opposite sides thereof. Reference numeral 36denotes an annular shoulder at the proximal end of catheter section 18.The proximal end of bolster (“retention”) balloon 24 rests againstshoulder 36 when in expanded, inflated use position.

[0048]FIGS. 6 and 7 show enlargements of retention balloon 24 mounted totube section 18 and show that the proximal end of the balloon 24 isadjacent to and tapers toward the proximal end of tube 18. Retentionballoon 24 is formed of a selectively collapsible and inflatablematerial and is mounted coaxially around the proximal end of section 18so that the extreme ends of each element are substantially flush (or atleast closely adjacent to) with one another.

[0049]FIG. 7 is a longitudinal section of FIG. 6, which illustratesinternally of tube section 18 an optional intralumenal balloon 38 in acollapsed state. When inflated the intralumenal balloon 38 acts as aanti-reflex valve (ARV) and if inflated sufficiently so that the patientproximal end of balloon 38 protrudes slightly (as shown in phantom inFIG. 7) beyond the proximal end of tube section 18, the intralumenalballoon also acts as an aid to insertion of the bowel managementassembly into the patient's rectum. This optional embodiment of thesystem includes an irrigation lumen 30 (described further herein), whichexits the patient proximal end of the catheter section 18 and can beconnected to an irrigation supply for inputting irrigant (such assaline) into the patient's rectum.

[0050]FIGS. 3 and 3A illustrate assembled and unassembled, respectively,the sub-assembly of the indwelling portion of the new system 10. Fromthe lower left to the upper right of FIG. 3 there is seen the patientproximal catheter section 18 extending just slightly beyond theretention balloon 24 and then the second catheter section 20. Cathetersection 20 is a cylindrical tube when completely open. It is formed witha very thin wall from a soft elastic material which results in acollapsible tube that when collapsed, such as by the anal sphinctermuscles, creates a very small profile. As this section of the catheteris left in place for very extended periods of time in the patient's analregion this collapsibility is important to prevent loss of the patient'ssphincter tone, as could result over time if a large diameter rigid tubewhere in such place. The optimal durometer range for section 20 isbetween 5A to 49A shore hardness. A first, proximal, end of the secondcatheter section 20 is connected to the distal or second end of thefirst catheter section 18. Catheter section 20 may be constructed as oneunitary tube of singular durometer hardness, thickness and diameter. Anexample of a suitable material for making trans-sphincter cathetersection 20 is silicone rubber, 30 SH polydimethylsiloxane and fumedsilica.

[0051] Toward the patient distal end of catheter section 20 there ismounted an optional faceplate 41 which mounts surrounding the tube 20and has preferably at least two sections 42 extending therefrom. Eachextension 42 can have loops or other connectors 44 thereon to facilitateattachment of the faceplate strap 40 to the patient to keep it in place.Finally, in FIG. 3, at the patient distal end of catheter section 20there is connected an extruded multi-lumen member 46 (shown in enlargedperspective, in FIG. 11) for permitting inflation/deflation of theballoons and flushing of the rectum, if desired. An end view of assembly10 is provided in FIG. 13, showing the relative positions of the strap40 and the multi-lumen catheter. An enlarged sectional view (rotated) inFIG. 14 better illustrates the connection of the multi-lumen member 46with the assembly at catheter section 18. An example of a suitablematerial for forming multi-lumen member 46 is silicone rubber, 57SHpolydimethylsiloxane and fumed silica.

[0052] In the exploded view, FIG. 3A, further elements of thesubassembly are seen which are hidden or not clear in FIG. 3. This viewillustrates retention balloon 24 in its expanded state beforeapplication to catheter section 18. The extensions 24A of thesymmetrical balloon on each end are annular. In FIG. 7 it is seen moreclearly how extensions 24A are folded under and inwardly so as to sealflat against the exterior wall at opposite ends of catheter section 18.

[0053] The figures also show the substantially spherical shape ofretention balloon 24. This shape is important because it seats naturallyin the patient's rectum to prevent leaking around the retention balloon.The shape of the balloon is important to prevent damage to the rectalwall and to achieve optimum sealing to prevent leakage and toeffectively funnel fecal matter into the proximal opening of cathetersection 18. Thus, the shape needs to be substantially spherical, notelliptical or torrodial.

[0054] The size of the balloon when inflated is not only critical toprevent leakage but also to prevent migration of the new system 10 outof the rectum. The optimal size for balloon 24 for the normal adultpatient is between 44 cc and 69 cc. It has been shown in the literaturethat a volume of 90 cc is sufficient to trigger a defecatory responseand thus the retention balloon should not be sized to reach this volume.The minimum of 44 cc is critical in order to prevent leakage and outwardmigration from the rectum of the patient. The size of the balloon asexpressed by a length to diameter ratio is 0.75 at the low end of theinflation range, 44 cc, (i.e., the balloon length is 1.35 inches and theballoon diameter would then be 1.8 inches) and 0.61 at the upper end, 69cc (i.e., a balloon length of 1.35 inches and a balloon diameter of 2.32inches). It is to be understood that all sizes given herein are for anaverage adult patient and can be adjusted proportionally for othernon-average patients. The retention balloon 24 is inflated via a lumen34, which opens into the balloon. The lumen is connected via amulti-lumen member 46 to an inflation device, such as a syringe, filledwith air or saline or some other biocompatible fluid. The inflationdevice limits the volume of inflation medium infused to a volume thatresults in the inflation of the balloon to the desired range of 44 to 69cc.

[0055] An example of a suitable material from which to form retentionballoon 24, in order to achieve the desired results is silicone rubber,30SH polydimethylsiloxane and fumed silica. Alternatively, the retentionballoon material itself could limit the size if a material or structurewas used that would only expand to the optimum size. An example of suchmaterial would be polyimide. An example of such a structure would be astiff mesh impregnated into an otherwise elastic material such assilicone that would mechanically limit the retention balloon size wheninflated. In turning to FIG. 3A, to the right of the retention balloon24 is shown a second balloon 38 which is illustrated in its collapsedposition. Balloon 38 is also illustrated in FIG. 7 collapsed in solidlines and inflated in broken lines. When inflated, balloon 38 fills thelumen of catheter section 18 to block reflux and facilitates insertionof the system into a patient.

[0056] Further with reference to FIG. 3A, catheter section 18 is shownthen to the right of balloon 38. To the right of catheter section 18 areshown two small TEFLON tubes 48 which interconnect paired small lumen inthe multi-lumen catheter 46 to corresponding openings to paired lumen inrectal catheter section 18. An optional radiopaque marker 50 ispreferably annular and is useful for accurately determining the locationof and position of the assembly portion within the rectum of thepatient. Marker 50 is formed for example of material such as a tungstensilicone mixture, which is biocompatible, but easily detected byradiograph. To the right of radiopaque marker 50 in FIG. 3A is shown thetrans-sphincter catheter section 20, the midsection of catheter 12.FIGS. 3 and 3A also illustrate the positioning of the faceplate 40 as itis mounted by a through hole onto the patient distal end of mid-cathetersection 20. A bridge section or drain tube connector band 52 isillustrated to the right of element 40 in FIG. 3A and also is visible inFIG. 3. Bridge section 52 permits the third, patient distal segment ofcatheter 12, segment 22 to be connected in abutting relationship withmidsection 20, by a slip fit of the sections 20, 22 over (or optionally,under) the segment 52. Extruded multi-lumen member 46 is illustrated atthe right of FIG. 3A and is shown in part, enlarged in FIG. 11 forclarity. In this embodiment, the multi-lumen member 46 is relativelyflat and elongated and bears a large central lumen 30 flanked by twosmaller lumen 32, 34 on opposite sides of lumen 30, as previouslydiscussed.

[0057]FIGS. 1 and 2 illustrate three ports (for example, luer-styleconnectors), which are connectable to the various lumens in multi-lumenmember 46. The larger central port 54 attaches to large lumen 30A in themulti-lumen member and is used for connection of a syringe or otherinfusion device in order to infuse irrigants or medications. An optionalport 56 connects to one of the small optional lumens (e.g., 32 a) in themulti-lumen member 46 for inflation and deflation of the optionalintralumenal balloon 38 with a syringe or other appropriate device. Theother small optional port 58 connects to small lumen 34 a, in themulti-lumen member 46 in order to inflate and deflate the retentionballoon with a syringe or other appropriate device.

[0058]FIGS. 4 and 5 illustrate the subassembly of the third cathetersegment 22. Segment 22 connects at a patient proximal end 22A to thedistal end of the trans-sphincter mid-segment 20 and the opposite,patient distal end 22B to a connector 66, which is adapted forconnection to a collection bag for example as illustrated at 60 in FIG.15. The third catheter section 22 is formed of a non-collapsible tubeconstructed of a material that is stiff enough to maintain its shape tominimize kinking and facilitate drainage of the tube, but soft enough tobe “milked” by a care professional to force through fecal material.Optional application of a coating to the exterior of section 2 canfacilitate milking thereof and optional internal coating of section 22facilitates flow-through of feces by decreasing friction against theinternal side wall.

[0059] Catheter 22 as shown has an optional sampling/flushing port 62(shown most clearly in FIG. 5) to provide access to the lumen of section22 for taking fecal samples or for flushing to clean the catheter. Inorder to prevent bacterial contamination of the catheter and to also aidin reduction of odor to fecal build up in the catheter, frequentflushing through the optional sampling/flushing port 62 is preferred. Acover for port 62, 63 of any suitable variety is also desirable.

[0060] The connector assembly 66 illustrated at end 22B of catheter 22includes a sleeve 64 spacedly along the length of catheter 22 to receiveand retain the connector assembly, which attaches 22B to collection bag60. It may be a heat-shrinkable band or other suitable retention meansas desired. As shown in FIG. 5 connector assembly 66 fits into the end22B and then is adapted, also with an optional O-ring (e.g. 67), toconnect in a sealing manner to the bag. A closure portion 68 is alsodesirable for closing off the connector assembly 64 preventing leakagewhen the bag is separated from catheter portion 22. If desired, theclosure portion 68 may be connected by a string, strip, cord or otherpiece 70 to end 26.

[0061] System 10 catheter section 22 empties into a collection bag 60,which can be hung by the bedside to collect fecal waste matter. FIG. 15illustrates waste collection bag 60, which is considerably larger thanwhat would ordinarily be used for a colostomy or urinary bag and the bagmay be left in place for long periods of time without having to beemptied. It is expected that bag 60 will have approximately a threeliter capacity, and be provided with a hook 72 for hanging on the bed orchair and of course a connector 73 for connection to the catheterconnector assembly 64 in a sealing manner. The waste bag 60 alsooptionally carries a drain tube holster 74, such as the U-shapedconnector illustrated, for example, and a clamp 76 for sealing off thecollection bag drain tube 82. Clamp 76 desirably carries a button 78 orother connector, which slips into holster 74 or otherwise attaches tobag 60. Closure portion 75 is also desirable for preventing leakage fromthe bag connector 73 when the bag is not connected to the catheterportion 22 of the bowel management system 10. An outlet tube 82 is alsoprovided for draining out the contents of the bag. It is preferred thatthe bag 60 be suitable for folding up because it is rather long; inorder to prevent it from dragging on the floor. Clamp 76 carrying thebutton holster connector 78 is useful for sealing off collection bagdrain tube 82 by pinching it. Also, Cap 80, which is preferably attachedto the holster 74 is useful for blocking the open tip (not shown) of bagdrain tube 82.

[0062] Another optional feature of the new bowel management system isthe provision of a faceplate which would serve as a retention mechanismto prevent internal migration of the bowel management system 10, as wellas to prevent rotation of the trans-sphincter catheter section 20 of thedevice. Such a faceplate 41 can be mounted on the bridge section 52 asillustrated, in FIGS. 1 and 2, as one useful example. The faceplate cantake the form of a strap, wedge, donut, etc. and would preferably bemade of silicone, foam or other soft material to avoid irritation of thepatient's skin.

[0063]FIGS. 1 and 2 also illustrate a clip assembly 21 for attachment ofthe assembly 10 to a sheet, bedclothes, etc. It is to be understood thatthe illustrated embodiment is merely one useful assembly foraccomplishing this task. As shown, an elastomeric band surrounds asimple pinch clip for gripping fabric or other thin material for thepurpose of holding the assembly in position.

[0064] Other useful stabilizing devices are conceived.

[0065] Use of the New Bowel Management System:

[0066] For insertion of bowel management system 10 into a non-ambulatorypatient it is preferred that the patient be in the left side downposition, if possible, although other positions may be utilized ifnecessary due to the patient's clinical condition. The procedure forinsertion is performed using recognized aseptic techniques asappropriate.

[0067] A device is selected with the appropriate trans-sphinctercatheter section length, usually 4 cm for a female patient, or 6 cm fora male patient. And the rectum of the patient is examined to confirm norectal impaction and to be sure that no lesions or strictures existwhich would preclude use of the device. A 60 cc syringe is filled with35 cc-40 cc water and a 30 cc syringe is filled with 20 cc water. The 30cc syringe is attached to the intralumenal balloon connector and theintralumenal balloon 38 is filled with the 20 cc's of fluid.

[0068] Lubricant is applied to patient proximal end of the deviceincluding the protruding intralumenal balloon 38, the deflated retentionballoon 24 and the patient's anus. Using the protruding end of theintralumenal balloon as an introducer, the patient proximal end ofcatheter section 18 is guided through the anus and into the distalrectum.

[0069] The 60 cc syringe is attached to the retention balloon connector58 and the retention balloon 24 is inflated with the syringe contents(in this example, 35 cc-40 cc water). The catheter connector assembly 66is connected to the waste collection bag connector 73 and bag 60 ispositioned at bedside so that the catheter drainage tube 22 is nottwisted or kinked. This allows for unobstructed fecal matter flow fromthe catheter 22 into bag 60.

[0070] After the catheter system is inserted into the patient's rectumand connected to the drainage bag, the 30 cc syringe is used tocompletely aspirate the 20 cc of water (or air) from intralumenalballoon 38. The 30 cc syringe is disconnected from the intralumenalballoon connector.

[0071] Catheter/Bowel Lumenal Patency is Confirmed by Performing theFollowing Procedure:

[0072] The patient is placed in a slight head up position to promotedrainage, the gravity irrigation or enteral feeding bag is filled withone liter of warm tap water and hung from an IV pole two to three feedabove the height of patient's anus. The irrigation bag administrationset is connected to the catheter irrigation port 54. After the caretakerverifies the connection to the correct catheter port, gravity irrigationis begun. Large stool pieces are broken up by a combination ofirrigating and manual douching (i.e. constricting outflow and squeezingthe drainage tube repeatedly). Irrigation is discontinued when stoolpieces are no longer present in the effluent.

[0073] Irrigation of the patient's rectum can be performed using agravity bag or by using a syringe. In the gravity bag method it isnecessary to provide a waste collection bag with at least two liters ofavailable volume. A standard gravity irrigation or enteral feeding bagwith pre-attached administration set is used to infuse about a liter ofwarm tap water into the patient's anus at a flow rate of about one literin six to ten minutes. The irrigation bag administration set isconnected to the catheter system irrigation port and the 30 cc syringe(filled with 20 cc of fluid) is attached to the intralumenal balloonconnector and the intralumenal balloon 38 is filled with the 20 cc's offluid.

[0074] With the patient in a slight head down position the flow controlvalve on the irrigation bag set is opened and fluid is allowed to drainby gravity into the rectum and colon. If leakage occurs past theretention balloon during irrigation more water is injected into theretention balloon up to a maximum inflation volume of 50 cc.

[0075] The infused irrigant is permitted to remain as long as prescribedby physician. Then the 20 cc volume of fluid with which the intralumenalballoon was inflated is removed via syringe and the mixed fluid andfeces are allowed to drain out of the rectum and colon. If necessary,the patient's position is modified to slight head up. Once irrigation iscomplete the administration set is disconnected from the catheterirrigation port. Any additional fluid that was injected into theretention balloon is removed by syringe via the retention balloonconnector. If necessary the retention balloon may be completelyaspirated and refilled to normal use volume (about 35 to about 40 cc).

[0076] If irrigation is performed using a syringe instead of a gravitybag preparations are similar, ensuring that sufficient space isavailable in the waste collection bag, and then a syringe is preparedwith about 60 cc of warm tap water. A 30 cc syringe is prepared withabout 20 cc of air or water and attached to the intralumenal balloonconnector and the intralumenal balloon is inflated. The syringe isconnected to the catheter irrigation port. With the patient in a slighthead down position the irrigant is slowly injected into the rectum andcolon. As with the gravity bag irrigation method, any leakage can behandled by further inflating the retention balloon. Similarly, irrigantis permitted to dwell for a prescribed time and then the fluid isaspirated from the intralumenal balloon with a syringe to allow drainageof fluid and feces out of the rectum and colon. If necessary thepatient's position can be modified. Again, if extra fluid was introducedinto the retention balloon it can now be released and the waste bagemptied if necessary.

[0077] The system irrigation port can be useful for administeringmedications or enema solutions. In this case, the port is preferablyflushed first with about 10 cc to about 20 cc of water before and afteradministration of enema/medication solution. A syringe is filled withthe desired solution to be introduced and a 30 cc syringe is filled withabout 20 cc of air or water. After inflating the intralumenal balloon,the solution is injected and the catheter irrigation lumen is flushed asindicated. The syringe is then disconnected from the irrigation port andthe solution is permitted to dwell for the prescribed time. Theintralumenal balloon is then deflated, preferably by use of a 30 ccsyringe, as previously described.

[0078] The flush/sampling port of the system can also be used to drawsamples of fecal mater by use of a catheter tip syringe attached to theflush/sampling port. This can be very useful for monitoring a patient'sprogress and for testing purposes.

[0079] In view of the foregoing, it will be seen that the severalobjects of the invention are achieved and other advantages are attained.Although the foregoing includes a description of the best modecontemplated for carrying out the invention various modification s areconceivable.

[0080] As various modifications could be made in the constructionsherein described and illustrated without departing from the scope of theinvention it is intended that all matter contained in the foregoingdescription or shown in the accompanying drawings shall be interpretedas illustrative rather than limiting.

We claim:
 1. A bowel management system for use in a patient comprising:a waste collection catheter having at least two distinct sections ofvarying durometer hardness including: a first section which is patientproximal and which is disposed in the patient's rectum in normal useposition, having a first end and a second end, and a durometer hardnessin the range of about 50A to about 90A, so that the catheter patientproximal section is stiff enough to automatically maintain an openposition for free flow of bowel waste when in normal use position with aretention balloon inflated, yet is soft and pliable enough to permitfolding longitudinally for ease of insertion into the rectum of thepatient; a second section having a first end connected to the second endof the patient proximal section, and a second end, and a durometerhardness in the range of about 5A to about 49A, so that the secondsection can be positioned and retained in the anal canal of the patientfor extended periods without distending the sphincters or causingdiscomfort; and a selectively collapsible, substantially sphericalretention balloon attached coaxially and exterior of the patientproximal first catheter section such that the proximal-most end of theretention balloon is coincident to the proximal-most first end of thepatient proximal first section of the waste collection catheter, thesubstantially spherical retention balloon having an inflated size so asto be sufficiently large enough to retain the patient proximal end ofthe catheter in the patient's rectum without being so large as totrigger a defecatory response in the patient.
 2. The system of claim 1,and further comprising a lumened member which is substantially smallerin diameter than the waste collection catheter and which has a first endand a second end, the first end of the lumened member being connected tothe patient proximal first section of the waste collection catheter andbeing in fluid communication with the selectively collapsible retentionballoon, and wherein the second end of the lumened member is connectableto a port for introduction or removal of fluid from the retentionballoon, for selective inflation and deflation of the retention balloonas necessary for insertion, retention or removal of the rectal catheterpatient proximal segment to or from the patient's rectum.
 3. The systemof claim 2, wherein the lumened member has at least two independentlumens, each of the lumens being connectable at the second end of thelumened member to a port for introduction or removal of fluid from thesystem, one of the two lumens being in fluid communication with thefirst end of the patient proximal segment of the waste collectioncatheter, to thereby permit introduction of treatment substances to thepatient's rectum.
 4. The system of claim 1, wherein the retentionballoon has an inflated length-to-diameter ratio in the range of about0.75 to about 0.61, with a volume of about 44 cc to about 69 cc.
 5. Thesystem of claim 4, wherein the retention balloon has a length of 1.35inches and a diameter of 1.8 inches.
 6. The system of claim 4, whereinthe retention balloon has a length of 1.35 inches and a diameter of 2.32inches.
 7. The system of claim 1, and further comprising an intralumenalballoon mounted to an interior of the patient proximal first segment ofthe waste collection catheter.
 8. The system of claim 7, wherein theintralumenal balloon is in fluid communication with a lumen of thelumened member to thereby permit selective inflation and deflation ofthe intralumenal balloon and to function as an anti-reflux device. 9.The system of claim 3, and further comprising an intralumenal balloonmounted to the patient proximal end of the waste collection catheter,wherein the lumened member has a first lumen, a second lumen and a thirdlumen, the first lumen being in fluid communication with the selectivelycollapsible retention balloon to thereby permit selective inflation andcollapse the retention balloon as necessary for insertion, retention orremoval of the rectal catheter patient proximal first segment to or fromthe patient's rectum, the second lumen being in fluid communication withthe inside of the patient proximal first segment of the waste collectioncatheter, to thereby permit introduction of substances to the patient'srectum, and the third lumen being in fluid communication with theintralumenal balloon.
 10. The system of claim 1, and further comprisinga third section of the waste collection catheter, which is positionedpatient distal in normal use.
 11. The system of claim 10, wherein thethird section of the waste collection catheter is coated internally witha substance to facilitate flow-through of waste matter from the patient.12. The system of claim 10, wherein the patient distal third section ofthe waste collection catheter is coated externally with a substance tofacilitate “milking” of the waste collection catheter by a caretaker forthe patient.
 13. The system of claim 10, wherein the patient distalthird section of the collection catheter is coated internally with asubstance to facilitate flow-through of waste matter from the patientand coated externally with a substance to facilitate “milking” of thewaste collection catheter by a caretaker for the patient.
 14. A bowelmanagement system for use in a patient comprising: a waste collectioncatheter having at least two distinct sections of varying durometerhardness including: a first section which is patient proximal and whichis disposed in the patient's rectum in normal use position, having afirst end and a second end, and a durometer hardness in the range ofabout 50A to about 90A, so that the catheter patient proximal section isstiff enough to automatically maintain an open position for free flow ofbowel waste when in normal use position with a retention ballooninflated, yet is soft and pliable enough to permit foldinglongitudinally for ease of insertion into the rectum of the patient; asecond section having a first end connected to the second end of thepatient proximal section, and a second end, and a durometer hardness inthe range of about 5A to about 49A, so that the second section can bepositioned and retained in the anal canal of the patient for extendedperiods without distending the sphincters or causing discomfort; and athird section of the waste collection catheter, which is positionedpatient distal in normal use, wherein the third section of the catheterhas a flush port to thereby permit the infusion of sufficiently largevolumes of fluid into the system to permit irrigation of the patient'sbowel.
 15. The system of claim 10, wherein the patient distal thirdsegment is formed of a non-latex material to ensure against allergicreactions by the patient and the caregiver.
 16. The system of claim 10,and further comprising a selectively openable and closeable access portin the patient distal third segment of the waste collection catheter tothereby permit access to the internal catheter for sampling andinsertion of medication and fluids.
 17. The system of claim 1, andfurther comprising a connector for permitting facile, releasableattachment of the system to the patient.
 18. The system of claim 1, andfurther comprising at least one flexible strip connected adjacent to thesecond end of the second section of the waste collection catheter, tothereby provide optional means by which to releasably attach the wastecollection catheter to the non-ambulatory patient to stabilize andsecure the system in use position.
 19. The system of claim 1, andfurther comprising a face plate of soft, pliable material, the faceplatebeing disposed adjacent to the second end of the second section of thewaste collection catheter to thereby provide stability to the system inuse position.
 20. The system of claim 10, and further comprising aclosure member connectable to the second end of the patient distal thirdsegment of the waste collection catheter.
 21. The combination of a bowelmanagement system for use in a non-ambulatory patient and a wastecollection bag, the bowel management system comprising: a wastecollection catheter having at least two distinct sections of varyingdurometer hardness including: a patient proximal first section, which isdisposed in the patient's rectum in normal use position, having a firstend and a second end, and a durometer hardness so that the catheterpatient proximal section is stiff enough to automatically maintain anopen position for free flow of bowel waste when in normal use position,yet is soft and pliable enough to permit folding longitudinally for easeof insertion into the rectum of a patient; a second section having afirst end connected to the second end of the patient proximal firstsection, and a second end sufficiently spaced from the first end thatthe second section can be positioned and retained in the anal canal ofthe patient and having a durometer hardness to permit the retention ofthe second section in the patient for extended periods without causingdiscomfort or lesions in the patient; and a waste collection bag adaptedfor secure, leak-proof connection to the waste collection catheter andwhich is sized sufficiently large enough to receive fecal waste from thepatient for extended periods, in the range of at least four hours. 22.The combination of claim 21, and further comprising a patient distalthird section having a first end connected to the second end of thesecond section, and a second end, which is patient distal-most when inuse, the third section being flexible enough to remain open forflow-through of waste through the catheter to a waste collection bag andbeing adapted for secure, leak-proof connection to the waste collectionbag.
 23. The combination of claim 22, the system further comprising aselectively collapsible, substantially spherical retention balloonattached around the patient proximal section such that the proximal-mostend of the retention balloon is coincident to the proximal-most firstend of the patient proximal section of the waste collection catheter,the substantially spherical balloon having a size when not collapsedsufficiently large to retain the patient proximal end of the catheter inthe patient's rectum without being so large as to trigger a defecatoryresponse in the patient.
 24. The combination of claim 21, the systemfurther comprising a lumened member which is substantially smaller indiameter than the waste collection catheter and which has a first endand a second end, the first end of the lumened member being connected tothe patient proximal portion of the waste collection catheter and beingin fluid communication with the selectively collapsible retentionballoon.
 25. The combination of claim 21, the system further comprisinga connector at the second end of the patient distal segment of the wastecollection catheter, to thereby permit removable connection of thesystem to the waste collection bag.
 26. The combination of claim 21,wherein the waste collection bag comprises an attachment mechanism forremovably attaching the waste collection bag to a support device for thepatient.
 27. The combination of claim 22, wherein the waste collectionbag includes a retention mechanism for permitting the waste collectionbag to be folded against itself and releasably retained in such positionin order to prevent the bag from dragging on the ground or other supportsurface.
 28. The combination of claim 21, wherein the waste collectionbag has attached a closeable drainage hose and a closure member forsealing a free end of the drainage hose when the drainage hose is not inuse.
 29. A waste collection bag for use with a patient bowel managementsystem, the bag comprising: a body portion having a volume ofapproximately three liters, the body portion having an end which ispositioned upwardly when connected to the system for use, the upper enddefining an opening adapted for releasable connection to an end of apatient waste collection catheter; an attachment mechanism for removablyattaching the waste collection bag to a support device for the patient;a retention mechanism for permitting the waste collection bag to befolded against itself and releasably retained in such position in orderto prevent the bag from dragging on the ground or other support surface;a closeable drainage hose; and a closure member for sealing a free endof the drainage hose when the drainage hose is not in use for emptyingwaste from the waste collection bag.
 30. The waste collection bag ofclaim 29, wherein the bag is provided on an external surface thereofwith indicia for indicating the approximate volume of patient body wastematerial in the waste collection bag.
 31. A method for inserting a bowelmanagement system into a patient, the method comprising: (a) providing abowel management system, the system having: a waste collection catheterhaving at least two distinct sections of varying durometer hardnessincluding: a first section which is patient proximal and which isdisposed in the patient's rectum in normal use position, having a firstend and a second end, and a durometer hardness in the range of about 50Ato about 90A, so that the catheter patient proximal section is stiffenough to automatically maintain an open position for free flow of bowelwaste when in normal use position with retention balloon inflated, yetis soft and pliable enough to permit folding longitudinally for ease ofinsertion into the rectum of a patient; a second section having a firstend connected to the second end of the patient proximal section, and asecond end, and a durometer hardness in the range of about 5A to about49A, so that the second section can be positioned and retained in theanal canal of the patient for extended periods without distending thesphincters or causing discomfort; and a selectively collapsible,substantially spherical retention balloon attached coaxially andexterior of the patient proximal first catheter section such that theproximal-most end of the retention balloon is coincident to theproximal-most first end of the patient proximal first section of thewaste collection catheter, the substantially spherical retention balloonhaving an inflated size so as to be sufficiently large enough to retainthe patient proximal end of the catheter in the patient's rectum withoutbeing so large as to trigger a defecatory response in the patient; (b)folding the patient proximal first end of the waste collection catheterlongitudinally; (c) inserting the folded patient proximal first end ofthe waste collection catheter into the patient's rectum sufficiently farthat the selectively collapsible, substantially spherical retentionballoon is entirely within the patient's rectum; and d) securing thewaste collection catheter in the position to which it has been insertedso that the catheter does not become separated from the patient duringan extended period of time, in the range of hours, while the patient'sbody waste is permitted to drain out of the patient's body through thewaste collection catheter.
 32. A method for inserting a bowel managementsystem into a patient, the method comprising: (a) providing a bowelmanagement system, the system having: a waste collection catheter havingat least two distinct sections of varying durometer hardness including:a first section which is patient proximal and which is disposed in thepatient's rectum in normal use position, having a first end and a secondend, and a durometer hardness in the range of about 50A to about 90A, sothat the catheter patient proximal section is stiff enough toautomatically maintain an open position for free flow of bowel wastewhen in normal use position with retention balloon inflated, yet is softand pliable enough to permit folding longitudinally for ease ofinsertion into the rectum of a patient; a second section having a firstend connected to the second end of the patient proximal section, and asecond end, and a durometer hardness in the range of about 5A to about49A, so that the second section can be positioned and retained in theanal canal of the patient for extended periods without distending thesphincters or causing discomfort; and a selectively collapsible,substantially spherical retention balloon attached coaxially andexterior of the patient proximal first catheter section such that theproximal-most end of the retention balloon is coincident to theproximal-most first end of the patient proximal first section of thewaste collection catheter, the substantially spherical retention balloonhaving an inflated size so as to be sufficiently large enough to retainthe patient proximal end of the catheter in the patient's rectum withoutbeing so large as to trigger a defecatory response in the patient; b)inflating an intralumenal balloon in the patient proximal end of thewaste collection catheter to the extent that the intralumenal balloonextends slightly beyond the proximal-most end of the catheter, tothereby provide a curved tip for ease of introduction of the catheterinto the patient's rectum (c) inserting the patient proximal first endof the waste collection catheter into the patient's rectum sufficientlyfar that the selectively collapsible, substantially spherical retentionballoon is entirely within the patient's rectum; and (d) securing thewaste collection catheter in the position to which it has been insertedso that the catheter does not become separated from the patient duringan extended period of time, in the range of hours, while the patient'sbody waste is permitted to drain out of the patient's body through thewaste collection catheter; and (e) deflating the intralumenal balloon inthe patient proximal end of the waste collection catheter to permit freeflow of body wastes from the patient.
 33. The method of claim 31,wherein securing the waste collection catheter in the position to whichit has been inserted includes the step of inflating the substantiallyspherical retention balloon so that the ratio of balloonlength-to-diameter is in the range of about 0.75 to about 0.61.
 34. Themethod of claim 32, wherein securing the waste collection catheter inthe position to which it has been inserted includes the step ofinflating the substantially spherical retention balloon so that theratio of balloon length-to-diameter is in the range of about 0.75 toabout 0.61.
 35. A method for managing an incontinent patient's bowel,the method comprising: (a) providing a bowel management system, thesystem having: a waste collection catheter having at least two distinctsections of varying durometer hardness including: a first section whichis patient proximal and which is disposed in the patient's rectum inrange of about 50A to about 90A, so that the catheter patient proximalsection is stiff normal use position, having a first end and a secondend, and a durometer hardness in the enough to automatically maintain anopen position for free flow of bowel waste when in normal use positionwith retention balloon inflated, yet is soft and pliable enough topermit folding longitudinally for ease of insertion into the rectum of apatient; a second section having a first end connected to the second endof the patient proximal section, and a second end, and a durometerhardness in the range of about 5A to about 49A, so that the secondsection can be positioned and retained in the anal canal of the patientfor extended periods without distending the sphincters or causingdiscomfort; and a selectively collapsible, substantially sphericalretention balloon attached coaxially and exterior of the patientproximal first catheter section such that the proximal-most end of theretention balloon is coincident to the proximal-most first end of thepatient proximal first section of the waste collection catheter, thesubstantially spherical retention balloon having an inflated size so asto be sufficiently large enough to retain the patient proximal end ofthe catheter in the patient's rectum without being so large as totrigger a defecatory response in the patient; (b) inserting the firstsection of the waste collection catheter into the patient's rectum; (c)connecting an end opposite the first section of the waste collectioncatheter to a waste collection vessel; (d) confirming patentcy of thewaste collection catheter; (e) permitting body wastes to flow throughthe waste collection catheter into the waste collection container; (f)emptying the waste collection container from time to time as necessarywhen the waste collection container becomes filled.
 36. The method ofclaim 35, and further comprising, securing the first section of thewaste collection catheter in position by attaching the waste collectioncatheter to the patient with one or more connection devices.
 37. Themethod of claim 36, wherein the first section of the waste collectioncatheter is secured in position by attaching the catheter to the patientwith strips of tape.
 38. The method of claim 35, wherein the firstsection of the waste collection catheter is secured in positioninternally of the patient by inflating the inflatable substantiallyspherical balloon that is attached around the patient proximal first endof the waste collection catheter to the point where the balloonlength-to-diameter ratio is in the range of about 0.75 to about 0.61.39. The method of claim 35, and further comprising irrigating thepatient's bowel by providing an intralumenal balloon mounted to thepatient proximal end of the waste collection catheter and a lumenedmember, wherein the lumened member has a first lumen, a second lumen anda third lumen, the first lumen being in fluid communication with theselectively collapsible retention balloon to thereby permit selectiveinflation and collapse the retention balloon as necessary for insertion,retention or removal of the rectal catheter patient proximal firstsegment to or from the patient's rectum, the second lumen being in fluidcommunication with the inside of the patient proximal first segment ofthe waste collection catheter, to thereby permit introduction ofsubstances to the patient's rectum, and the third lumen being in fluidcommunication with the intralumenal balloon; providing a further sectionto the waste collection catheter, the further section having a porttherein; infusing sufficiently large volumes of fluid into the system topermit irrigation of the patient's bowel and rinsing of the catheterfrom time to time, as necessary; inflating the intralumenal balloon toretain the fluid within the patient's bowel, and after a predeterminedinterval; releasing the irrigation fluid by deflating the intralumenalballoon and permitting the fluid to flow through the waste collectioncatheter into a waste collection vessel.
 40. The method of claim 35, andfurther permitting the patient's body wastes to flow into a wastecollection vessel having a size of at least approximately three liters.41. The method of claim 35, and further comprising providing the systemwith a lumened member which is substantially smaller in diameter thanthe waste collection catheter and which has a first end and a secondend, the first end of the lumened member being connected to the patientproximal first section of the waste collection catheter and being influid communication with the selectively collapsible retention balloon,and wherein the second end of the lumened member is connectable to aport for introduction or removal of fluid from the retention balloon,for selective inflation and deflation of the retention balloon asnecessary for insertion, retention or removal of the rectal catheterpatient proximal segment to or from the patient's rectum, wherein thelumened member has at least two independent lumens, each of the lumensbeing connectable at the second end of the lumened member to a port forintroduction or removal of fluid from the system, one of the two lumensbeing in fluid communication with the first end of the patient proximalsegment of the waste collection catheter, to thereby permit introductionof fluid treatment substances to the patient's rectum; and introducingfluid treatment substances to the patient's bowel via the lumenedmember.
 42. The method of claim 41, and further comprising retaining theintroduced treatment substances in the patient's bowel for a selectedperiod of time by, providing an intralumenal balloon mounted to thepatient proximal end of the waste collection catheter and, afterintroducing the treatment substances; inflating the intralumenal balloonto block the interior of the catheter; and then, after the selectedperiod of time, deflating the intralumenal balloon to permit passage offluids from the patient's bowel.